# K080620: Modification to 3M Tegaderm CHG Dressing

- Pathway: 510(k) (Special)
- Applicant: 3M Company-3M Health Care
- Decided: May 19, 2008 after 76 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K895920 (1991). 6 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063458: 3M Tegaderm CHG Dressing, 3M Company (2007) Summary page 1.
- K895207: Bioclusive* Transparent Film Dressing - New Claim, Johnson & Johnson International (1989) Summary page 1.
- K895353: Opsite I.V. 3000, Smith & Nephew United, Inc. (1989) Summary page 1.
- K973036: 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres, 3M Healthcare (1997) Summary page 1.
- (no number) SorbaView Ultimate Window Dressing: named in the summary without a submission number
- (no number) SorbaView 2000: named in the summary without a submission number

## Most influential descendants
- K121819: Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver (2012), 3 descendants of its own
- K153410: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (2017), 1 descendant of its own
- K163529: ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) (2017), 1 descendant of its own
- K251866: Tegaderm Post-Op Transparent Antimicrobial Dressing (2025), 0 descendants of its own
- K171908: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (2017), 0 descendants of its own

## Recalls of this device
- Aug 14, 2024 · Class II · Z-0038-2025: Contamination with foreign substance matter

## Indications for use
3M Tegaderm CHG Dressings (Chlorhexidine Gluconate I.V. Securement Dressing), can be used to cover and protect catheter sites and to secure devices to skin. Common applications include IV catheters, other intravascular catheter and percutaneous devices.

Source page: https://510kreport.com/device/K080620
Methodology: https://510kreport.com/methodology